Complaint specialist (m/w/d)

EinleitungIn compliance with European MDD/MDR, FDA & other International Regulations, the Complaints Specialist will perform work under general management supervision. General scope of this position is to ensure compliance to the Complaints and Post Market Surveillance System with the responsibility of timely complaint initiation and assessment of regulatory geography reporting, complaint follow-up, coordination of complaint device returns, and collaboration with the cross-functional engineers and technicians for timely completion of the complaint investigation. This position requires frequent use and general knowledge of industry practices, techniques, and standards.AufgabenPrimary ResponsibilitiesProcessing of customer feedback ("complaints”), taking into account the requirements of ISO 13485 and all relevant medical device regulationsCentral recording of information by customers and sales/marketing Novanta about malfunctions and application problems.

Problems with Novanta products (especially medical devices) as a complaint fileAnalysis of defective products (internal and customer, supplier complaints) using quality tools (8 D report, 5 WHY and others)Evaluation of the analysis results to develop and initiate corrective and preventive measuresEvaluation of the analysis results with regard to complaint category (A, B, C or D), information to RA and QMB/safety commissioned for categories C and DReporting to the customer (and the relevant internal areas)Documentation of processes in accordance with regulatory requirementsRegular evaluation of processes (monthly and annually)Processing customer feedback on non-medical devices (taking into account the requirements from ISO 9001)Recording, analyzing, evaluating and documenting customer feedback on non-medical productsClose cooperation with Quality Operations Supervisor and quality engineer SupervisorWorking with SAP – different operations (e.g. complaints, material, etc.)Participates in meetings for the launch of new projectsCooperation on customer, internal quality auditsDifferent types of analysis (scrap, error rate).QualifikationAusbildung, Erfahrung und KompetenzenBachelor mit Fachrichtung Maschinenbau oder Elektrotechnik oder vergleichbare Technikerausbildung mit BerufserfahrungKenntnisse der Normen EN ISO 13485 und ISO 9001 zwingend notwendigKenntnisse der Qualitätsinstrumente (5 Why, Ishikawa, 8 D-Bericht) wünschenswertOrientierung in der technischen DokumentationMS-Office-AnwendungenKonzentrierter, zuverlässiger und selbständiger ArbeitsstilAktiver Ansatz und Beteiligung am InnovationsprozessStrenge Einhaltung der Qualitäts-, Sicherheits- und Umweltvorschriften und Umsetzung der QualitätsrichtlinienSehr gute deutsche und englische Sprachkenntnisse zwingend erforderlichReisebereitschaftDie Bereitschaft zu Dienstreisen zu allen Novanta-Standorten und Geschäftskontakten von Novanta (weniger als 10% der Arbeitszeit)